FDA UDI
In Commercial Distribution
🇺🇸 United States
Intra-Lock
DI: D742WCT50
·
Model: WCT_50
·
INTRA-LOCK INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Intra-Lock
- Primary DI
- D742WCT50
- Version / Model
- WCT_50
- Catalog Number
- WCT_50
- Company Name
- INTRA-LOCK INTERNATIONAL, INC.
- Labeler DUNS
- 131500998
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-29
- Public Version
- 1
- Public Version Date
- 2020-08-06
- Public Version Status
- New
- Public Device Record Key
- 03b397d2-8519-4832-aa25-537fa31bd0a5
Device Description
L-PRF White Cap Plain Z Tube (9 ml)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Hematology | 864.9245 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58496 | Blood collection set, noninvasive | A collection of sterile, noninvasive devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes and a separate blood access device (e.g., intravenous catheter), for the routine collection of multiple blood specimens from a patient, for clinical analyses. It consists of various device combinations that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder; the set may connect to, but does not contain, an invasive blood access device(s) [e.g., an intravenous catheter]. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D742WCT50 | HIBCC |
Customer Contacts
- Phone
- 8773300338
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK120048 | 0 |